Independently perform routine biophysical methods, data interpretation and report independently as specified in standard in-house SOPs, Client Test Methods and other written procedures. Assist scientific staff on client-specific experimental design, moderately complex professional tasks, report development, quality control, and research. These may include method feasibility, development, optimization, transfers, qualifications, validations and routine testing in both R&D and cGMP environments. Additionally, will be responsible for contributing to client interaction, interpretation and reporting of data for assigned research projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Independently perform laboratory activities including but not limited to reagent preparation, laboratory maintenance/monitoring of equipment, routine testing of client samples, and generation of routine cGMP and R&D reports.
- Perform a variety of BioPhysical laboratory experiments, tests and procedures following well-defined techniques and guidelines, including:
o Analytical Ultracentrifugation (AUC)
o Size Exclusion HPLC-MALLS (SEC-MALLS)
o Differential Scanning Calorimetry (DSC)
o Intrinsic Tryptophan Fluorescence (ITF)
o Fourier Transform Infrared (FTIR)
o Dynamic Light Scattering (DLS)
o Protein Binding via SPR-Biacore
o Circular Dichroism (CD)
- Analyze data and report results of experiments and procedures.
- Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work and data.
- Summarize data for complex reports.
- Assist in the monitoring of key project events.
- Troubleshoot unexpected/invalid results, prioritize workload and solve moderately complex problems.
- Review departmental procedures for accuracy of scope of work prior to initiation.
- Prepare Excel or Word tables for data evaluation.
- Provide detailed and accurate peer and technical review of documents, reports, and data.
- For cGMP and R&D grade routine testing, generate biophysical data and technical report (s) on-time with respect to internal and client deadlines.
- Maintain a weekly schedule to ensure all timelines are met.
Additional Duties and Responsibilities
- Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.
- Maintain a safe working environment by adhering to Company policies or procedures.
- Actively participate in laboratory maintenance.
- Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
- Perform assay and equipment troubleshooting with minimal guidance from senior members of the group.
- Independently compose high quality documentation including deviation reports and change control documentation with no/minimal guidance.
- Participate in client/sponsor relationships (e.g., technology transfer, conference calls and sharing of technical information).
- Create, review and edit SOPs, protocols and other data forms and testing documentation.
- Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
- Assist in training of junior staff.
- Participate in transferring and training of biophysical technical staff on methodology for which qualification has been successfully completed.
- Maintain up to date training records on all procedures and protocols applicable to work duties.
- Ability to work in a structured and regulated environment.
- Work productively in group situations as well as independently.
- Perform all other related duties as required.
- Bachelor’s Degree (B.S.), or equivalent, in biochemistry, chemistry or related discipline.
- 3-5 years related industry experience in a biophysical science area in the Pharmaceutical, Biotech or contract (CRO) laboratory environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
- Knowledge of basic protein /peptide biophysical techniques and ability to operate typical laboratory equipment, specifically HPLC, spectrophotometer, dialysis/buffer exchange via SPE, and other laboratory equipment a plus.
- Strong organizational and prioritization skills required.
- Attention to detail and accuracy a must.
- Must possess excellent interpersonal skills to maintain communication across functional groups.
- Must have strong written and verbal communication.
- Basic Microsoft Office skills are required.
- Ability to understand and use internal software programs such as LIMS required.
- Must be able to remain in a stationary position 50% of the time while performing laboratory tasks.
- Regularly observes, inspects, and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors.
- Frequently and accurately operate laboratory pipettes.
- Regularly lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds.
- General laboratory working conditions.
- Regularly wears protective clothing (cap, gloves, scrubs, lab coat, safety glasses).
- Regularly works with or near toxic or caustic chemicals.
- May be exposed to fumes or airborne particles.
- Regularly works at a chemical fume hood.
- Occasionally works near moving mechanical parts.
- May work with biohazards.
- Occasionally may be exposed to unpleasant odors.
- The employee may work with sharp objects (i.e., needles, glass pipettes, pipet tips).
- This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.